ObesityFundoRing_RYNCT07486765
FundoRing Roux-en-Y Gastric Bypass Versus FundoRing One Anastomosis Gastric Bypass
A study testing Laparoscopic FundoRing gastric bypass in people with Obesity and Roux-en-y Anastomosis Site, run by The Society of Bariatric and Metabolic Surgeons of Kazakhstan at 1 site in Kazakhstan.
Trial summary
Metabolic and bariatric surgery (MBS) is an effective and durable treatment of severe obesity and its co-morbidities. Gastric bypass is one of the main MBS procedures and is performed using various surgical techniques. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Roux-en-y Anastomosis Site, Reflux Gastritis
- What is being tested?
- Laparoscopic FundoRing gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteKazakhstan
- Study dates
- 4 Jul 2024to 13 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- BMI 30-50 kg/m2
Who cannot join
- BMI <30 and >50 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic FundoRing Roux-en-Y Gastric Bypass Versus FundoRingOAGB: a Randomized Clinical Trial
Metabolic and bariatric surgery (MBS) is an effective and durable treatment of severe obesity and its co-morbidities.
Gastric bypass is one of the main MBS procedures and is performed using various surgical techniques. The main postoperative bariatric complication after one anastomosis gastric bypass (OAGB) is bile reflux, and the main disadvantage of traditional Roux-en-Y gastric bypass (RYGB) is dumping syndrome.
Read more
The successful strategies for avoiding reflux esophagitis and other complication following gastric bypass is the use FundoRing method for gastric bypass with creation fundoplication employing the excluded (remnant) part of the stomach. Routine use of a modified fundoplication of the OAGB-excluded stomach to treat patients with obesity decreased acid and prevented bile reflux esophagitis significantly more effectively than standard OAGB. However, the anastomosis after OAGB is constantly bathed in bile. This was previously thought to significantly increase the risk of ulcers, but modern data shows that bile may even have a "protective" buffering effect, neutralizing acid, although the risk of alkaline gastritis remains. The results of trial of consequences of reflux bile flow from the intestine into the gastric pouch after OAGB are controversial. How does this affect the incidence of marginal ulcers due to enterogastric reflux? The answers to these questions remain unclear.
The aim of the study was to compare the incidence of distal gastric pouch inflammation and the likelihood of marginal ulcers in patients treated with the FundoRing Roux-en-Y gastric bypass versus the FundoRing OAGB.
Read the detailed description
Laparoscopic gastric bypass is a minimally invasive weight loss surgery that reduces the stomach's volume to 20 ml and reroutes the small intestine from the gastric pouch, bypassing the duodenum, into the jejunum, limiting food intake and reducing calorie absorption. This technique also involves creating an enteroenterostomy for a variant of the Roux-en-Y procedure. This procedure involves five small incisions, resulting in a faster recovery and fewer complications compared to traditional open surgery.
With an increasing global metabolic and bariatric surgery (MBS) experience, long-term studies have proven it an effective and durable treatment of severe obesity and its co-morbidities. MBS should be considered a safe and effective primary treatment option or when modern pharmacotherapy does not have an optimal clinical response.
Gastric bypass is one of the main MBS procedures and is performed using various surgical techniques. The main postoperative bariatric complication after one anastomosis gastric bypass (OAGB) is bile reflux, and the main disadvantage of traditional Roux-en-Y gastric bypass (RYGB) is dumping syndrome.
The successful strategies for avoiding reflux esophagitis and other complication following gastric bypass is the use FundoRing method for gastric bypass with creation fundoplication employing the excluded (remnant) part of the stomach. Routine use of a modified fundoplication of the OAGB-excluded stomach to treat patients with obesity decreased acid and prevented bile reflux esophagitis significantly more effectively than standard OAGB at 1 year in a randomized controlled trial]. However, the anastomosis after OAGB is constantly bathed in bile. This was previously thought to significantly increase the risk of ulcers, but modern data shows that bile may even have a "protective" buffering effect, neutralizing acid, although the risk of alkaline gastritis remains. The results of trial of consequences of reflux bile flow from the intestine into the gastric pouch after OAGB are controversial. How does this affect the incidence of marginal ulcers due to enterogastric reflux? The answers to these questions remain unclear.
Therefore, the primary objective of the study was to compare the incidence of distal gastric pouch inflammation and the likelihood of marginal ulcers in patients treated with the FundoRing Roux-en-Y gastric bypass versus the FundoRing OAGB.
- Being tested
- Laparoscopic FundoRing gastric bypass
- Medical subject headings
- Obesity, Esophagitis, Peptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic FundoRing gastric bypassProcedure or surgery
Also called FundoRing
Laparoscopic gastric bypass is a minimally invasive weight loss surgery that reduces the stomach's volume to 20 ml (separated stomach to gastric pouch (small part) and remnant (excluded, large) part) and reroutes the small intestine from the gastric pouch, bypassing the duodenum, into the jejunum, limiting food intake and reducing calorie absorption.
Additionally, the esophagus and the upper part of the gastric pouch were wrapped with the upper part (fundus) of the excluded (remnant) part of stomach using the FundoRing method.
| Study group | Role | What they receive |
|---|---|---|
| FundoRingRoux-en-Y | Experimental | Laparoscopic FundoRing Roux-en-Y gastric bypass includes two anastomosis: gastroenterostomy and enter-enteroanastomosis. Receives: Procedure: Laparoscopic FundoRing gastric bypass |
| FundoRingOAGB | Active comparator | Laparoscopic FundoRing one anastomosis gastric bypass includes only single gastro-enterostomy. Unlike the Roux-en-Y procedure, this technique does not require the creation of an enteroenterostomy. Receives: Procedure: Laparoscopic FundoRing gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the number of participants with postoperative reflux gastritis in each groups
Compare the number of participants with endoscopically detected incidence of postoperative reflux gastritis in each group.
Measured: 1, 3, 6, 12, 24, 36 month after surgery
Compare the number of participants with marginal ulcers of gastroenteroanastomosis in each groups
Number of participants with endoscopic Identification of the frequency of marginal ulcers in gastroenteroanastomosis in two groups
Measured: 1, 3, 6, 12, 24, 36 month after surgery
Change of body masse index (BMI) in two groups
Weight (kg) and height (meter) will reported combined as mean BMI in kg/m2 in each groups
Measured: 1, 2, 3 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start4 Jul 2024
- Primary completion12 Mar 2026
- Study completion13 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Society of Bariatric and Metabolic Surgeons of Kazakhstan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oral Ospanov, Professor, Principal investigator, The Society of Bariatric and Metabolic Surgeons of Kazakhstan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07486765
- Sponsor's protocol ID
- FundoRingRoux-en-Y
- Acronym
- FundoRing_RY
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic FundoRing Roux-en-Y Gastric Bypass Versus FundoRingOAGB: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07486765
- Acronym / sponsor ID
- FundoRing_RY / FundoRingRoux-en-Y
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The Society of Bariatric and Metabolic Surgeons of KazakhstanUniversity, hospital or other
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 12 Mar 2026 (actual)
- Study completion
- 13 Mar 2026 (actual)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metabolic and bariatric surgery (MBS) is an effective and durable treatment of severe obesity and its co-morbidities.
Gastric bypass is one of the main MBS procedures and is performed using various surgical techniques. The main postoperative bariatric complication after one anastomosis gastric bypass (OAGB) is bile reflux, and the main disadvantage of traditional Roux-en-Y gastric bypass (RYGB) is dumping syndrome.
The successful strategies for avoiding reflux esophagitis and other complication following gastric bypass is the use FundoRing method for gastric bypass with creation fundoplication employing the excluded (remnant) part of the stomach. Routine use of a modified fundoplication of the OAGB-excluded stomach to treat patients with obesity decreased acid and prevented bile reflux esophagitis significantly more effectively than standard OAGB. However, the anastomosis after OAGB is constantly bathed in bile. This was previously thought to significantly increase the risk of ulcers, but modern data shows that bile may even have a "protective" buffering effect, neutralizing acid, although the risk of alkaline gastritis remains. The results of trial of consequences of reflux bile flow from the intestine into the gastric pouch after OAGB are controversial. How does this affect the incidence of marginal ulcers due to enterogastric reflux? The answers to these questions remain unclear.
The aim of the study was to compare the incidence of distal gastric pouch inflammation and the likelihood of marginal ulcers in patients treated with the FundoRing Roux-en-Y gastric bypass versus the FundoRing OAGB.
Detailed description
Laparoscopic gastric bypass is a minimally invasive weight loss surgery that reduces the stomach's volume to 20 ml and reroutes the small intestine from the gastric pouch, bypassing the duodenum, into the jejunum, limiting food intake and reducing calorie absorption. This technique also involves creating an enteroenterostomy for a variant of the Roux-en-Y procedure. This procedure involves five small incisions, resulting in a faster recovery and fewer complications compared to traditional open surgery.
With an increasing global metabolic and bariatric surgery (MBS) experience, long-term studies have proven it an effective and durable treatment of severe obesity and its co-morbidities. MBS should be considered a safe and effective primary treatment option or when modern pharmacotherapy does not have an optimal clinical response.
Gastric bypass is one of the main MBS procedures and is performed using various surgical techniques. The main postoperative bariatric complication after one anastomosis gastric bypass (OAGB) is bile reflux, and the main disadvantage of traditional Roux-en-Y gastric bypass (RYGB) is dumping syndrome.
The successful strategies for avoiding reflux esophagitis and other complication following gastric bypass is the use FundoRing method for gastric bypass with creation fundoplication employing the excluded (remnant) part of the stomach. Routine use of a modified fundoplication of the OAGB-excluded stomach to treat patients with obesity decreased acid and prevented bile reflux esophagitis significantly more effectively than standard OAGB at 1 year in a randomized controlled trial]. However, the anastomosis after OAGB is constantly bathed in bile. This was previously thought to significantly increase the risk of ulcers, but modern data shows that bile may even have a "protective" buffering effect, neutralizing acid, although the risk of alkaline gastritis remains. The results of trial of consequences of reflux bile flow from the intestine into the gastric pouch after OAGB are controversial. How does this affect the incidence of marginal ulcers due to enterogastric reflux? The answers to these questions remain unclear.
Therefore, the primary objective of the study was to compare the incidence of distal gastric pouch inflammation and the likelihood of marginal ulcers in patients treated with the FundoRing Roux-en-Y gastric bypass versus the FundoRing OAGB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FundoRingRoux-en-Y | Experimental | Procedure: Laparoscopic FundoRing gastric bypassLaparoscopic FundoRing Roux-en-Y gastric bypass includes two anastomosis: gastroenterostomy and enter-enteroanastomosis. |
| FundoRingOAGB | Active comparator | Procedure: Laparoscopic FundoRing gastric bypassLaparoscopic FundoRing one anastomosis gastric bypass includes only single gastro-enterostomy. Unlike the Roux-en-Y procedure, this technique does not require the creation of an enteroenterostomy. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 30-50 kg/m2
Key exclusion criteria (1 listed)
- BMI <30 and >50 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic FundoRing gastric bypassAlso: FundoRingLaparoscopic gastric bypass is a minimally invasive weight loss surgery that reduces the stomach's volume to 20 ml (separated stomach to gastric pouch (small part) and remnant (excluded, large) part) and reroutes the small intestine from the gastric pouch, bypassing the duodenum, into the jejunum, limiting food intake and reducing calorie absorption. Additionally, the esophagus and the upper part of the gastric pouch were wrapped with the upper part (fundus) of the excluded (remnant) part of stomach using the FundoRing method. | Procedure or surgery | FundoRingOAGB, FundoRingRoux-en-Y |
Primary outcome
Compare the number of participants with postoperative reflux gastritis in each groups
Time frame: 1, 3, 6, 12, 24, 36 month after surgery
Compare the number of participants with endoscopically detected incidence of postoperative reflux gastritis in each group.
Compare the number of participants with marginal ulcers of gastroenteroanastomosis in each groups
Time frame: 1, 3, 6, 12, 24, 36 month after surgery
Number of participants with endoscopic Identification of the frequency of marginal ulcers in gastroenteroanastomosis in two groups
Change of body masse index (BMI) in two groups
Time frame: 1, 2, 3 year after surgery
Weight (kg) and height (meter) will reported combined as mean BMI in kg/m2 in each groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oral Ospanov, Professor principal investigator
The Society of Bariatric and Metabolic Surgeons of Kazakhstan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic FundoRing gastric bypass in people with Obesity and Roux-en-y Anastomosis Site, run by The Society of Bariatric and Metabolic Surgeons of Kazakhstan at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the number of participants with postoperative reflux gastritis in each groups (time frame: 1, 3, 6, 12, 24, 36 month after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.